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2. Intended purpose
Intended Use
Measuring of body temperature from the forehand to determine
body temperature as an indicator for illness and for monitoring
of therapies and recovery processes as well as surface
temperature of objects such as milk bottle/bathwater or ambient
temperature.
Indications
The device is intended to be used by patients (self-monitoring) or
third person in healthcare institutions and home care for
suspicion of abnormal body temperature (fever, hypothermia)
and measuring and monitoring of temperature.
Intended user & patient population
A responsible person with reading ability can use the device to
measure body temperature by forehead. The intended patients
are for infants, children, adults of the general population.
Contra-indications
Any breached or compromised skin.
The device is not suitable for hypothermia patients.
Clinical benefits to be expected
Ensure accuracy of the temperature measurement.
3. Important Safety Instructions
● Follow instructions for use. This document provides important
product operation and safety information regarding this device.
Please read this document thoroughly before using the device
and keep for future reference.
● This device may only be used for the purposes described in
these instructions. The manufacturer cannot be held liable for
damage caused by incorrect application.
● Never immerse this device in water or other liquids. For
cleaning or disinfection, please follow the instructions
in the «Cleaning and Disinfecting» section.
● Do not use this device if you think it is damaged or notice
anything unusual.
● Do not attempt to repair, modify or open this device.
● A basic physiological effect called vasoconstriction can occur in
the early stages of fever, resulting in a cool skin effect. The
recorded temperature using this thermometer can, therefore,
be unusually low.
● If the measurement result is not consistent with the patient's
finding or unusually low, double check the result by another
core body temperature measurement.
4
● This device comprises sensitive components and must be
treated with caution. Observe the storage and operating condi-
tions described in the «Technical Specifications» section.
● Ensure that children do not use this device unsupervised; some
parts are small enough to be swallowed.
● Do not use this device close to strong electromagnetic fields such
as mobile telephones or radio installations. Keep a minimum
distance of 3.3 m from such devices when using this device.
● Protect it from:
- Extreme temperatures
- Impact and dropping
- Contamination and dust
- Direct sunlight
-
Heat and cold
-
Extreme Humidity
● If the device is not going to be used for a prolonged period the
batteries should be removed.
● Do not attempt to take temperatures at other sites, such as
wrist, shin, as it may result in false readings.
● Store and operate the device under suitable temperature and
humanity as indicated in the «Technical Specifications» section.
Please report any serious incident ,injury or adverse event
●
that has occurred in relation to the device to the manufacturer/
European authorized representative (EC REP),and to the
competent authority.
It's recommended that this product is inspected every two years,
●
after mechanical impact, liquid ingress or if malfunction is
assumed. Testing must be carried out by trained personnel
following the manufacturer's instructions.
Professional users must follow the country specific applicable
●
medical devices ordinance.
Do not touch or clean the senor with a hard object.
●
If the patient temperature is influenced (e.g. incubator, heating
●
blanket) the measurement result provided by this device shall not
be used to determine the presence/absence of fever.
●
Regular cleaning and disinfection based on using environment is
advised to avoid spreading of contact transmittable diseases.
● The residual risks and undesirable side effects that may be
related to the use of this device can include but may not be
limited to the following:
- Deviation of measurement results
- Treatment delay
-
Contamination
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